Senior Manager, Internal & Third Party Operations Audit
University degree in Biology, Chemistry, Pharmacy or engineering
- with experience in (bio)pharmaceutical manufacturing and quality operations
- with awareness of GMP and international standards
- awareness of other GXP and exposure to Health Authorities is a plus
- At least 10 years of experience in a pharmaceutical/Biological environment covering various areas: QA, R&D, production, QC and project management roles.
- Strong knowledge of regulatory and GMP regulations (European, US, Japanese, WH0 ...).
- Demonstrated leadership ability and experience in influencing improvement activity to ensure implementation of appropriate CAPAs.
- Qualified/Certified auditor is a plus.
- Excellent English writing skills.
- Communications skills to ensure issues, risks and opportunities are well understood and that effective actions are put in place.
- Strong problem solving and analytical skills.
- Customer focused; ability to understand requirements of local sites.
- In depth knowledge and expertise of quality systems, specially of key/ core, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation).
- Good understanding of vaccines or similar biologics manufacturing and controls (primary and secondary operations) as well as raw material manufacturing technologies.
- Ability to adapt, work under uncertainty and accommodate flexible work demands.
- Global perspective; cultural sensitivity.
- Self-motivated; Sense of urgency.
- Travel: 40-50%.
The primary responsibility of the Senior Manager, I&TPO Audit is to:
- Ensure continuous GMP, Regulatory & Corporate compliance through audits of GMP processes for the GSK Vaccines sites, Global Functions and External Supply Sites.
It encompasses functions and sites involved in the manufacture of sterile bulk antigens and aseptically formulated vaccines registered worldwide (i.e. North America, Europe & Asia). It also includes the internal and external Vaccines supply chain for sterile bulk viral/bacterial/polysaccharide antigen processes, vaccine formulation, filling, packaging, distribution and manufacture of novel adjuvant.
- Support continuous improvement of audit system and processes.
- Support and embed a 'One Audit' culture through audits and assessments at GSK Vaccines and Third Parties, i.e. Strategic Global Suppliers, Contractors, Licensees, Alliance Partners & future business partners.
- Lead and participate in audit/assessment engagements. Activities include, but are not limited to team coordination, monitoring of progress towards plan, liaison with auditee, scope definition and overall assessment of internal controls for the applicable process(es) / risk(s).
- Whether leading or participating on audits, provide leadership to ensure that audits deliver fit-for-purpose, risk based assurance that is responsive to the current business and risk environment. Collaborate across Internal & TPO Audit Team to ensure holistic consideration of risk and business context. Ensure that audits are delivered to the highest level of quality, and are conducted efficiently, maximizing team productivity.
- Support the strategic Regulatory Inspection Management activities, i.e. assessments in preparation of strategic inspections, Health Authorities commitments verification.
- Serve as a business partner to enhance GSK's risk management capabilities and actively identify and share good practices and improvement opportunities.
- Ensure transparent, balanced, open communication with business stakeholders to provide timely updates on audit progress and potential issues throughout the lifecycle of the audit.
- Remain current with industry trends and changes in the regulatory and GXP standards.
- Provide interpretation and consultation to project teams on (new/updated) regulations, guidelines, compliance status and policies and procedures.
- Support development and continuous improvement of audit system and processes, including qualification of new auditors.
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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